Sareum Regulatory News (SAR)

Sareum Holdings PLC

("Sareum" or the "Company")

Trading Statement

Cambridge, UK, 25 May 2021 - Sareum Holdings plc (AIM: SAR), the specialist drug development company delivering targeted small molecule therapeutics to improve the treatment of cancer and autoimmune diseases, provides the following trading update ahead of its financial year ending 30 June 2021.

SDC-1801 - Autoimmune diseases

As noted in the Company's interim results published on 23 April 2021 (the "Interim Results"), Covid-19 continues to impact the Contract Research Organisations with which Sareum is working to complete the preclinical development of SDC-1801 for autoimmune disease. While initially the impact on development timelines was minimal, it has increased and is causing further delays to the conduct of the final preclinical studies the Company needs to complete on SDC-1801 prior to filing an exploratory Clinical Trial Application (CTA). As a result of these delays, the Company now expects these final toxicity and safety studies to complete in Q3 2021 and a CTA for SDC-1801 to be filed in Q4, subject to no further delays. The Company had previously guided that the filing of the CTA was expected mid-year 2021. Should the CTA be filed in Q4 2021, this may enable the Company to commence first clinical trials in early 2022, subject to financing.

SDC-1801 - Covid-19 studies

The UKRI-funded Covid-19 research project for SDC-1801 is expected to complete on schedule with the experimental phases finishing in June and the data analysis to complete shortly thereafter. The Company will provide a further update once the relevant data are available.

As noted in the Interim Results, initial results from this research are encouraging and demonstrate that SDC-1801 reduces the levels of cytokines associated with Acute Respiratory Distress Syndrome in human lung cells infected with SARS-CoV-2.

If the completed studies are successful, the Company plans to explore the possibility for further UK government funding from the recently launched AGILE clinical development platform, which has been established to fund Phase 1 trials and fast-track the development of potentially ground-breaking Covid-19 treatments. These activities are expected to run in parallel with the broader SDC-1801 development plan.

SDC-1802 - Cancer immunotherapy

The Company continues to work on the design of the translational studies needed to define the optimal cancer application prior to completing toxicology and manufacturing studies.

SRA737 - Solid cancers

Sareum is not aware at this time of any additional updates from Sierra Oncology ("Sierra") regarding its plans for the further development of SRA737. The Company is, however, encouraged by the appointment of Mark Kowalski, MD, PhD as Chief, Research and Early Development, to focus on, among other things, the ongoing evaluation of development opportunities for Sierra's pipeline assets. Furthermore, Sareum continues to believe that the licensing agreement amendment signed in November 2020 between CRT Pioneer Fund and Sierra will help expedite the SRA737 development programme.

The Company looks forward to providing a more comprehensive business update at the time of the Full-year Results, expected in October 2021.

Dr Tim Mitchell, CEO of Sareum, commented:

"The delays in completing the preclinical data package for SDC-1801, prior to our planned filing to begin clinical studies, are an unfortunate consequence of the current pandemic environment that is affecting many organisations. Despite these delays, we continue to work diligently towards this important milestone for this novel and promising candidate and are targeting CTA filing in Q4 2021 to enable first clinical trials to commence early in 2022, subject to financing.

"We look forward to reporting the results from the UKRI-funded studies that are investigating the potential of SDC-1801 to reduce the excessive inflammatory response seen in severe Covid-19. Positive results, that confirm our early findings, will enable us to explore further opportunities to develop SDC-1801 in this indication, in parallel with our broader autoimmune programme."

The information contained within this announcement is deemed by the Company to constitute inside information under the Market Abuse Regulation (EU) No. 596/2014

About Sareum

Sareum is a specialist drug development company delivering targeted small molecule therapeutics to improve the treatment of cancer and autoimmune diseases. The Company aims to generate value through licensing its candidates to international pharmaceutical and biotechnology companies at the preclinical or early clinical trials stage.

Sareum is advancing internal programmes focused on distinct dual tyrosine kinase 2 (TYK2) / Janus kinase 1 (JAK1) inhibitors through preclinical development as therapies for autoimmune diseases, including the 'cytokine storm' immune system overreaction to Covid-19 and other viral infections, (SDC-1801) and cancer immunotherapy (SDC-1802).

Sareum also has an economic interest in SRA737, a clinical-stage oral, selective Checkpoint kinase 1 (Chk1) inhibitor that targets cancer cell replication and DNA damage repair mechanisms. Preliminary Phase 2 and comprehensive preclinical data suggest SRA737 may have broad application in combination with other oncology and immune-oncology drugs in genetically defined patients.

SRA737 was discovered and initially developed by scientists at The Institute of Cancer Research in collaboration with Sareum, and with funding from Sareum and Cancer Research UK. SRA737 was licensed by CRT Pioneer Fund (CPF) to Sierra Oncology Inc. Sierra continues to explore options that would enable the development of SRA737 to advance.

Sareum Holdings plc is listed on the AIM market of the London Stock Exchange, trading under the ticker SAR. For further information, please visit the Company's website at www.sareum.com 

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